The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2638-2017·Announced 2017-07-05

Beckman Coulter Access System-GI Monitor Recalled for Biotin Interference

Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a susceptibility to interference rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beckman Coulter Inc. is recalling the Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687. The recall involves 249,597 units total, with 9,388 units distributed in the United States. The product was distributed to numerous countries worldwide, including the United States, Canada, and various nations in Europe, Asia, Africa, and the Americas.

The recall is being conducted because the Access immunoassays are susceptible to biotin interference. This susceptibility may impact the accuracy of the test results. The source text does not specify reported illnesses, injuries, or deaths associated with this recall.

Healthcare providers and laboratories should stop using the affected product and contact Beckman Coulter for further instructions or replacement units. Consumers should consult their healthcare provider if they have recently used this test.

The recalled product

Product
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lots

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Beckman Coulter Inc.

See all →

Same hazard · biotin interference

See all →

Similar recalls