Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
This recall has been terminated (originally issued October 31, 2007).
- Company
- Bio-Rad Laboratories
- Recall Initiated
- September 5, 2007
- Posted
- October 31, 2007
- Terminated
- November 15, 2007
- Recall Number
- Z-0065-2008
- Quantity
- 46
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
Distribution
Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
Lot / Code Info
Lot 131BHH, Catalog # 26174
Root Cause
Error in labeling
Action Taken
On 9/5/07 a letter titled "IMPORTANT PRODUCT INFORMATION" was sent to customers advising them of the issue and requesting customers make a note of the correction in their laboratory procedures and/or any existing copies of the package insert. On 9/19/07 the firm sent a second letter (dated 9/18/07) via DHL titled "URGENT PRODUCT CORRECTION" and supplied a corrected package insert to replace the original insert sent.