Z-0686-2013Class II

NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is...

Name: Z-0686-2013 NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is...
Creator: Perkinelmer
Published: 2012-11-26
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2012-11-26 / Terminated / root cause: manufacturing process

FDA source

Perkinelmer began a recall of NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino... on 2012-11-26. FDA classified it as Class II and gives the reason as "Truncated V-Bottomed Microplate Wells used in assays contain defective wells". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0686-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-26
Posted: 2013-01-16
Terminated: 2014-03-07
Recalling firm: Revvity Health Sciences, Inc.
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.
Product code: JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Reason for recall: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot Numbers: 617341, 619236

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0686-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0686-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0687-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0688-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0689-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16
Z-0690-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-16

Product code JNB

K021541Class IINeogram Pku Tandem Mass Spectrometry KitPerkinelmer Life Sciences / cleared 2002-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)