Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Barbiturate Enzyme Immunoassay

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Barbiturate Enzyme Immunoassaysee related information
Date Initiated by FirmSeptember 08, 2011
Date PostedJanuary 24, 2012
Recall Status1 Terminated 3 on January 25, 2012
Recall NumberZ-0846-2012
Recall Event ID 60750
510(K)NumberK032764 
Product Classification Enzyme immunoassay, barbiturate - Product Code DIS
ProductBarbiturate 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
Code Information Large Kits Catalog number 0141, lot # 1105052, exp 11/25/12; small kits catalog number 0140, lot # 1105053, exp 11/25/12.
Recalling Firm/
Manufacturer		 Lin-Zhi International Inc
670 Almanor Ave
Sunnyvale CA 94085-3513
For Additional Information ContactAnnie Hung
408-732-3856
Manufacturer 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 2		Nonconforming Material/Component
ActionLin-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.
Quantity in Commerce72 small kits, 12 large kits.
DistributionWorldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DIS
-
-