FDA Device Recall Z-0039-2024: AB Sciex, LLC

Recall Res Number

Z-0039-2024

Recalling Firm / Manufacturer

AB Sciex, LLC

FEI Number

3008935545

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-08-30

Date Posted

2023-10-05

Date Terminated

N/A

Product Code

DOP

Event Number

92810

Product Quantity

10

Product Description Citrine QTRAP Mass Spectrometer, Part Number 5063685

Reason for Recall In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.

Action Details An URGENT: RUO and MEDICAL DEVICE FIELD ACTION notification letter dated 7/20/23 was sent to customers. Actions to be taken by the Customer/User: SCIEX will provide a replacement nut for eligible sources and systems. Instructions will be provided to guide you through the replacement of the nut. The replacement parts with installation instructions are estimated to begin shipping in October 2023. SCIEX is currently notifying affected customers of the upcoming countermeasure. Upon availability, SCIEX will send you the replacement nut with instructions on how to install it on the ion source probe. We sincerely apologize for any inconvenience that this may cause you. SCIEX aims to provide you with products of the highest quality. If you have any questions regarding this notice, please contact https://sciex.com/aboutus/ contact-us or https://sciex.com/support/request-support.

Distribution Pattern US Nationwide.

Code Information / Serial Numbers UDI-DI: 00842365100540; Serial Numbers: DD250051901, DD250172009, DD250182009, DD230001804, DD250111910, DD250132004, DD250091909, DD250101910, DD250192010, CN10011707PT

WATERS CORPORATION Registration: 1218959 View Registration
Agilent Technologies, Inc Registration: 2916205 View Registration
WATERS TECHNOLOGIES CORPORATION Registration: 3000221947 View Registration
SHIMADZU U.S.A. MANUFACTURING, INC. Registration: 3001040364 View Registration
Agilent Technologies Singapore (International) Pte Ltd. Registration: 3003423869 View Registration
Thermo Finnigan LLC Registration: 3003809634 View Registration
SERCON LIMITED Registration: 3007386004 View Registration
AB SCIEX LP Registration: 3008336863 View Registration
Agilent Technologies Inc. Registration: 3009189893 View Registration
AB SCIEX Pte. Ltd. Registration: 3009715051 View Registration
SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV. Registration: 3010607747 View Registration
AGENA BIOSCIENCE INCORPORATED Registration: 3010962166 View Registration
SCITEK GLOBAL CO.,LTD Registration: 3043088937 View Registration
LABPEAK CO.,LTD Registration: 3043138885 View Registration
WALLAC OY Registration: 8043909 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
HITACHI HIGH-TECH CORP., NAKA DIVISION Registration: 9614673 View Registration
WATERS TECHNOLOGIES IRELAND, LTD. Registration: 9616673 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0039-2024

Recall Parameters & Description

Related Establishments / Registrations

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