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Terminated

ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

FDA Recall Z-0927-2013 · Posted 2013-03-08

Recalling FirmInnominata Dba Genbio
Recall StatusTerminated
Product CodeLSR
Date Initiated2013-02-11
Date Terminated2013-08-27
Product Quantity195

Reason for Recall

Multiple incidents of low-reacting assay plates.

Firm Action

The firm, Innominata dba GenBio, sent an "Urgent Product Correction" letter dated February 11, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the listed questions to determine sites risk and take the appropriate actions. For questions regarding this issue, customers may contact Bio-Rad Technical Support at : 1-800-224-6723, option #2, and then option #3 for assistance.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911590IMMUNOWELL BORRELIA (LYME)TESTGeneral Biometrics, Inc. · 1991-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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