VITROS Immunodiagnostic Products HBsAg Controls recall
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the…
Why was VITROS Immunodiagnostic Products HBsAg Controls recalled?
The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.
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?
Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908 Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18
- Product
- VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 1,621 units
- Distribution
- Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
- Recall date
- November 2, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)