Recall Z-0846-2012
Lin-Zhi International Inc · initiated September 8, 2011
Product
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
Codes / lots: Large Kits Catalog number 0141, lot # 1105052, exp 11/25/12; small kits catalog number 0140, lot # 1105053, exp 11/25/12.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0846-2012
- Initiated
- September 8, 2011
- Posted by FDA
- January 24, 2012
- Terminated
- January 25, 2012
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Quantity
- 72 small kits, 12 large kits.
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.
- Recalling firm
- Lin-Zhi International Inc, Sunnyvale, CA