Home / Recalls / Alere San Diego, Inc. / Z-1702-2024

Z-1702-2024 Class II Ongoing

Recalled by Alere San Diego, Inc. — San Diego, CA

FDA device recall Z-1702-2024 was initiated by Alere San Diego, Inc. on March 1, 2024 and is designated Class II. Reason for recall: There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abras… The recall status is ongoing. Affected quantity: 559 units.

Recall Details

Product Type
Devices
Report Date
May 8, 2024
Initiation Date
March 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
559 units

Product Description

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Reason for Recall

There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of United Kingdom, Netherlands and Kenya.

Code Information

All Lots/ UDI:

Other recalls by Alere San Diego, Inc.

  • Z-1508-2022 Class II — The Cholestech LDX¿ System combines enzymatic methodology and solidphase techno (June 24, 2022)
  • Z-2475-2019 Class II — Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the (February 15, 2019)
  • Z-0418-2018 Class II — Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 2 (November 14, 2017)
  • Z-0588-2017 Class II — Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the prod (October 12, 2016)
  • Z-2778-2016 Class III — LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette i (August 2, 2016)
  • Z-2357-2016 Class I — Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Prod (July 11, 2016)
  • Z-2361-2016 Class I — Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usag (July 11, 2016)
  • Z-2359-2016 Class I — Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usag (July 11, 2016)
  • Z-2362-2016 Class I — Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9900 (July 11, 2016)
  • Z-2358-2016 Class I — Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 (July 11, 2016)

FDA data resources