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Terminated

Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing

FDA Recall Z-0846-2012 · Posted 2012-01-24

Recalling FirmLin-Zhi International Inc
Recall StatusTerminated
Product CodeDIS
Date Initiated2011-09-08
Date Terminated2012-01-25
Product Quantity72 small kits, 12 large kits.

Reason for Recall

Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.

Firm Action

Lin-Zhi sent a letter via e-mail dated September 8, 2011 to customers with information regarding the recall. The e-mail identified the product description, lot number, description of nonconformity and corrective actions to be taken. Each customer and distributor was then contacted by regulatory affairs personnel by phone on September 9, 2011 or September 12, 2011. Customers and distributors were contacted to determined whether they wanted a replacement of the affected product. Customers that wished for replacements of the affected product was asked to correctly dispose of the product with the lot numbers listed. For questions or concern call 408-732-3856.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032764BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)Lin-Zhi International, Inc. · 2003-11-03

Official Source

View FDA Recall →

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

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