What is STA Liatest Free Protein S kit used for?

It is intended for quantitative antigenic assay of free Protein S in human citrated plasma using immuno-turbidimetric method on STA-R and STA Compact devices.

What is the recall for?

The recall concerns potential out-of-range results and underestimation of free Protein S levels in normal plasmas.

How many units are affected?

369 units globally distributed, including the US and many countries.

Are there any reported injuries?

No injuries or deaths are reported in the recall notice.

What should I do if I have this kit?

Stop using the kit immediately and follow the manufacturer’s recall instructions provided by Diagnostica Stago via recall notification email.

How can I identify if my kit is affected?

Check the REF: 00516 model and the listed UDIs and lot numbers: 271971, 272859, 273018, 273426.

Where can I get more information?

Refer to the FDA enforcement recall page linked to the recall notice.

Will I receive a refund or replacement?

The manufacturer will provide refund or replacement guidance as part of the recall process.

How long does the process take?

Refunds or replacements typically take several weeks after submission.

Is this recall specific to hospitals or laboratories?

The recall covers worldwide distribution through health care distributors and laboratories using the kit.

Should I discard the kit or destroy it?

Follow the recall instructions from Diagnostica Stago to ensure proper handling.

What should I document?

Save recall emails, record kit REF, UDIs, lot numbers, and dates of purchase for replacement processing.

Diagnostica Stago STA Liatest Free Protein S Kit Recalled for 369 Units Worldwide in 2026

Diagnostica Stago recalled 369 STA Liatest Free Protein S kits worldwide on 2026-02-04 due to potential out-of-range results. The defect may underestablish protein S levels in normal plasmas. Stop using immediately and follow the manufacturer’s recall instructions via email.

Diagnostica Stago Health & Personal Care Medical DevicesModel/Catalog Number (REF): 00516UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516UDI: (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516

Quick Facts at a Glance

Recall Date: February 4, 2026
Hazard Level: HIGH
Brand: Diagnostica Stago
Category: Health & Personal Care
Sold At: Unknown
Geographic Scope: 1 states
At-Risk Groups: GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

1Stop using the product until you confirm whether it is included in the recall.
2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand: Diagnostica Stago
Product type: STA Liatest Free Protein S immuno-turbidimetric assay kit
Model numbers: Model/Catalog Number (REF): 00516, UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516, UDI: (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516, UDI: (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516, UDI: (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516, Lot numbers: 271 971, 272 859, 273 018, 273 426
Sold at: Unknown
Where affected: ALL

Recall Timeline

Key dates and source checks for this recall record.

Recall announced
February 4, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.

Hazard Information

The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diagnostica Stago, Inc. or your healthcare provider for instructions. Notification method: E-Mail

About This Product

The STA Liatest Free Protein S kit measures free protein S in human plasma. It is used in laboratory screening and diagnostic testing.

Why This Is Dangerous

An out-of-range result can lead to underestimating free Protein S levels, potentially affecting clinical interpretation in normal-range plasmas.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Clinicians may receive inaccurate Protein S results, potentially affecting patient assessment and treatment decisions. There is no reported physical harm from the kit itself.

Practical Guidance

How to identify if yours is affected

1) Verify REF 00516 on the kit label.
2) Check UDI strings and lot numbers 271971, 272859, 273018, 273426.
3) Confirm global distribution status and recall date.

Where to find product info

Refer to the FDA recall page (recall_number Z-1491-2026) for official instructions.

What timeline to expect

Refunds or replacements typically take 4-8 weeks after processor submission.

If the manufacturer is unresponsive

Document attempts to contact Diagnostica Stago
Escalate to FDA recall program if company is unresponsive
Consider legal counsel for prolonged inaction

How to prevent similar issues

Verify product recalls before purchase
Keep records of lot numbers and UDI codes
Follow all official recall communications

Documentation advice

Retain recall emails, purchase receipts, kit labels showing REF and UDIs, and correspondence with Diagnostica Stago.

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Key Facts

Global distribution across the US and multiple countries
UDIs listed for four lots
Hazard: potential out-of-range results underestimating free Protein S in normal plasmas

View Original Recall on FDA - Medical Devices