Z-2126-2015Class II

WIZARD2 5-detector, 550 samples

Name: Z-2126-2015 WIZARD2 5-detector, 550 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 WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma counter is intended to detect and count gamma radiation emitted by... 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-2126-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-07-20
Terminated: 2017-08-04
Recalling firm: Revvity Health Sciences, Inc.
Product: WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 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: 53 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: DG03130211 DG04130287 DG05130344 DG06129306 DG08129516 DG08129541 DG08129542 DG08129582 DG08129593 DG10129714 DG10129720 DG11095720 DG12118684 DG12129915 DG12129916 DG12129917 DG12129918 SG24700050 SGWZ01150227 SGWZ02150229 SGWZ02150230 SGWZ03150232 SGWZ04140102 SGWZ06140105 SGWZ10150251 SGWZ11140117 SGWZ11140119 SGWZ12130002 SGWZ16140130 SGWZ16140133 SGWZ17140136 SGWZ19140145 SGWZ20130007 SGWZ21140154 SGWZ24140160 SGWZ25140161 SGWZ29140169 SGWZ30140174 SGWZ31140176 SGWZ34130036 SGWZ39130046 SGWZ42130052 SGWZ42140205 SGWZ42140206 SGWZ43130054 SGWZ43140208 SGWZ43140209 SGWZ46140215 SGWZ46140216 SGWZ47140217 SGWZ47140218 SGWZ48130079 SGWZ50130085

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2126-2015
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)