Recall Z-1840-2015— Bio-Rad Laboratories, Inc.
Class III · Terminated
Class III FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2015-05-13, terminated 2015-11-05. FDA's recall record names no specific 510(k) clearance for this event. Product: The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.. Reason: The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error..
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-05-13
- Terminated
- 2015-11-05
- Firm location
- Redmond, WA, United States
Product description
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
Reason for recall
The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.