Z-0688-2013Class II

NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative...

Name: Z-0688-2013 NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative...
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 NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and... 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-0688-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-26
Posted: 2013-01-16
Terminated: 2014-03-07
Recalling firm: Revvity Health Sciences, Inc.
Product: NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Product code: JLA Conversion To Creatinine, Creatine
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: 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers: 618201, 619200, 618263

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0688-2013
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 JLA

K071649Class INeonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BWallac OY / cleared 2008-08-07

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)