The Recall Desk
ModerateFDA (Devices)·Z-0686-2013·Announced 2013-01-23

Perkinelmer Recalls Defective NEOGRAM Tandem Mass Spectrometry Kits

Perkinelmer is recalling 180 NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kits because they contain defective microplate wells.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Perkinelmer is recalling 180 units of the NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Product Number 3026-0030. The affected lots are 617341 and 619236, which were distributed nationwide.

The recall was initiated because the truncated V-bottomed microplate wells used in the assays contain defective wells. This kit is intended for in vitro diagnostic use by trained laboratory personnel to measure amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples to aid in screening for metabolic disorders.

No specific instructions for consumers are provided in the source text, as the product is intended for use by qualified laboratory personnel.

The recalled product

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
Manufacturer
Perkinelmer

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: 617341
  • 619236

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Perkinelmer under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →