FDA Device recall Z-1956-2016

Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitativ…

FDA Device
Class II
terminated
Published 2016-06-22

On 2016-06-22 the FDA classified a Class II recall of Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitativ… by Beckman Coulter, citing due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, c….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1956-2016
Classification	Class II
Status	terminated
Initiated	2016-05-17
Published	2016-06-22
Last updated	2026-09-13 11:54 UTC
Company	Beckman Coulter
Distribution	n/a

Product

Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

Reason

Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.

Identifiers

code_info	Serial No. 505143, 504805, 501368, 504231

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1956-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.