Ortho-Clinical Diagnostics Recalls VITROS HBsAg Controls Due to Performance Drift
Ortho-Clinical Diagnostics is recalling VITROS HBsAg Controls because signal/cutoff results may increase during the 5-day reconstituted timeframe, potentially affecting performance monitoring.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition indicates the product is not likely to cause adverse health consequences. The source text notes that the positive control remained within acceptable performance limits, and no injuries or illnesses are reported.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 1,621 units of VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598. The affected lots are 0860, 0870, 0880, 0890, and 0908, with expiration dates ranging from March 29, 2017, to January 29, 2018. These products were distributed nationwide in the United States and in several international markets, including Australia, Brazil, Canada, and the United Kingdom.
The recall was initiated because the signal/cutoff (s/c) results may increase throughout the allowed 5-day open-reconstituted timeframe. This increase may occur on both negative and positive controls. Although the positive control showed elevated results, it remained within acceptable performance limits. The controls are used to monitor the performance of VITROS Immunodiagnostic Systems for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg).
Healthcare facilities and laboratories should stop using the affected lots and contact Ortho-Clinical Diagnostics for instructions on returning the product. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when use
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 1,621
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distributed nationwide across the United States.
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