Bio-Rad Laboratories Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, manufactured by Bio-Rad Laboratories, Redmond, WA.
Brand
Bio-Rad Laboratories
Lot Codes / Batch Numbers
Lot 131BHH, Catalog # 26174
Products Sold
Lot 131BHH, Catalog # 26174
Bio-Rad Laboratories is recalling Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174 due to Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026