Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bi
FDA device recall Z-0065-2008 · posted 2007-10-31 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- Reason for recall
- Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LOM
- Quantity affected
- 46
- Distribution
- Nationwide: Kits were distributed to 27 hospitals, clinics and testing labs throughout the US.
- Date initiated
- 2007-09-05
- Date posted
- 2007-10-31
- Date terminated
- 2007-11-15
- Location
- Redmond, WA
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