Synchron LX System — Class II medical device recall Z-1400-2013

Terminated recall by Beckman Coulter Inc., reported 2013-06-05, distributed nationwide. Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer comp

Recall number	`Z-1400-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Beckman Coulter Inc., Brea, CA, United States
Recall initiated	2013-04-17
Classified	2013-05-24
Reported by FDA	2013-06-05
Terminated	2014-10-22
Distributed	Nationwide (US)
Countries outside the US	AE, AU, BE, CA, CH, CZ, DE, ES, FR, GB, GR, HK, IE, IT, JP, KW, LB, MA, NL, OM, PA, PY, QA, SE, SG, SK, TH, TN, TR, TW, ZA
Quantity	8,774 units
Reason classes	potency
Lot numbers	`M206209`
Model numbers	`A95550`

Product

Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

Reason for recall

Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1400-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.