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.
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.
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
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The STA Liatest Free Protein S kit measures free protein S in human plasma. It is used in laboratory screening and diagnostic testing.
An out-of-range result can lead to underestimating free Protein S levels, potentially affecting clinical interpretation in normal-range plasmas.
This recall is not part of a broader industry pattern.
Clinicians may receive inaccurate Protein S results, potentially affecting patient assessment and treatment decisions. There is no reported physical harm from the kit itself.
Refer to the FDA recall page (recall_number Z-1491-2026) for official instructions.
Refunds or replacements typically take 4-8 weeks after processor submission.
Retain recall emails, purchase receipts, kit labels showing REF and UDIs, and correspondence with Diagnostica Stago.
Model/Catalog Number (REF): 00516 UDI: (1) 01-03607450005165-11-241001-17-260131-271971-241-00516 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: 271971, 272859, 273018, 273426 Lot Code: 271971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516 Sold worldwide in US states including AZ, CA, CO, FL, GA, HI, IL, KY, MI, MN, MO, MT, NC, ND, NJ, NY, OH, PA, TN, TX, UT, VA, WA and many countries. Recall Date: 2026-02-04. Status:
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