Z-2128-2015Class II

Perkin Elmer WIZARD2 5-detector, 1 000 samples

Name: Z-2128-2015 Perkin Elmer WIZARD2 5-detector, 1 000 samples
Creator: Perkinelmer
Published: 2015-06-03
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2015-06-03 / Terminated / root cause: manufacturing process

FDA source

Perkinelmer began a recall of Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard" gamma counter is intended to detect and count gamma radiation... on 2015-06-03. FDA classified it as Class II and gives the reason as "Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results". 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-2128-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-07-20
Terminated: 2017-08-04
Recalling firm: Revvity Health Sciences, Inc.
Product: Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
Product code: JJJ Counter (Beta, Gamma) For Clinical Use
Reason for recall: Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to [email protected]
Quantity in commerce: 2 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.
Product codes and lots: Serial Numbers: Model: 2470-0150 (1 unit): SGWZ36130042 Model: 3470-0150 (1 unit): SGWZ19140141

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2128-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2125-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2126-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2127-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2128-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2129-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2130-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code JJJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)