Reported Jan 13, 2021 · Ongoing
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB…
Ortho Clinical Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Clinical Diagnostics Inc · 1001 US Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- VITROS Chemistry Products CKMB Slides(1)VITROS CKMB Slides (60
- Slide cartridge) Product Code8058232 (2)VITROS CKMB Slides (18
- Slide cartridge) Product Code8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 lot numbers) Extended Recalls: Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication 2 Reference, CL2021-182) 18 June 2021 Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication 3 Reference, CL2021-214) 18 August 2021 Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication 4 Reference, CL2021-274) , 1 November 2021 Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication 5 1075875000429410758750004201Reference, CL2023-244) , 27 October 2023 UDI: (1) (10758750004294) (2) (10758750004201 - Amount recalled
- Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units
Where it was sold
- Nationwide
Why it was recalled
VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
This product could cause temporary or reversible health problems — stop using it.
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