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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM

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 Class 2 Recall
Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM
see related information
Date Posted January 16, 2013
Recall Status1 Terminated on March 07, 2014
Recall Number Z-0686-2013
Recall Event ID 63771
Premarket Notification
510(K) Number
K021541 
Product Classification Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine - Product Code JNB
Product NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Code Information Lot Numbers: 617341, 619236
Recalling Firm/
Manufacturer
Perkinelmer
940 Winter Street
Waltham, Massachusetts 02451
Manufacturer Reason
for Recall
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation. Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.
Quantity in Commerce 180 kits (20 plates/kit)
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JNB and Original Applicant = PERKINELMER LIFE SCIENCES
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