Ortho-Clinical Diagnostics recalled 2,908 units of VITROS Chemistry Products LAC Slides on July 29, 2025. The recall affects lots from coating 0130 and above due to increased calibration failures that delay test results. The issue may impact patient management and was identified through an uptick in customer complaints.
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ortho-Clinical Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recall involves VITROS Chemistry Products LAC Slides, Catalog Number 8433880. Each sales unit contains five cartridges with 60 slides each, totaling 300 tests. The affected lots include coating 0130 and above, with specific lot numbers ranging from 3533-0130-2317 to 3533-0131-6128.
Calibration failures in the recalled slides can delay lac test results. For coating 0130, the average failure rate rose to 1% in 2025, compared to 0.06% for other coatings in the same year.
The recall follows an increase in customer complaints, indicating a significant risk in patient management. No specific injury numbers were reported.
Stop using the recalled slides immediately. Follow the recall instructions provided in the notification letter. Contact Ortho-Clinical Diagnostics or your healthcare provider for further guidance.
For assistance, contact Ortho-Clinical Diagnostics at their customer service line or visit their website. Additional information is available through the FDA recall notice.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.