VITROS Immunodiagnostic Products TSH Reagent Pack recall
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD…
Why was VITROS Immunodiagnostic Products TSH Reagent Pack recalled?
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 5040 (Expiry date 19 Dec 2016)
- Product
- VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD…
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Quantity
- Domestic: 2883, Foreign: 1261
- Distribution
- Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
- Recall date
- August 24, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)