Recall Z-0927-2013— Innominata Dba Genbio

Name: FDA recall Z-0927-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-11

Class II · Terminated

Class II FDA medical device recall by Innominata Dba Genbio, initiated 2013-02-11, terminated 2013-08-27. It names one FDA 510(k) clearance: K911590. Product: 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.. Reason: Multiple incidents of low-reacting assay plates..

Recalling firm: Innominata Dba Genbio
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Terminated: 2013-08-27
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K911590 — IMMUNOWELL BORRELIA (LYME)TESTGeneral Biometrics, Inc.·cleared 1991-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Multiple incidents of low-reacting assay plates.

Data sourced from openFDA. This site is unofficial and independent of the FDA.