Agency classClass IIOur severity:High FDA (Devices)·Z-0163-2016·Announced 2015-11-04

Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses or injuries, and the hazard is a component defect (incorrect tubing) rather than a high-risk pathogen or structural vehicle defect.

Plain-English summary

Abbott Laboratories, Inc. is voluntarily recalling 65 units of the ARCHITECT i2000SR System. The recall was initiated on September 9, 2015, and was classified as Class II by the U.S. Food and Drug Administration. The reason for the recall is the presence of incorrect tubing in the devices.

The affected systems are intended for in vitro diagnostic use only and are designed to perform automated immunoassay tests using chemiluminescent microparticle assay detection technology. The recall covers units distributed nationwide in the United States and internationally to France, the Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan.

The recall was initiated by the firm and was terminated on November 17, 2016. Abbott notified customers via letter. No specific instructions for consumers are provided in the source text, but the recall status is listed as terminated.

The recalled product

Product: ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
Manufacturer: Abbott Laboratories, Inc
Category: Medical Device — In Vitro Diagnostic Equipment
Hazard: component-defect
Affected units: 65

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 (20)

ISR03967
ISR04737
ISR01461
ISR01998
ISR01964
ISR02446
ISR02751
ISR02781
ISR05266
ISR04520
ISR01460
ISR01442
ISR01988
ISR03034
ISR01194
ISR01583
ISR01955
ISR02437
ISR03144
ISR03352

Distribution

Distributed nationwide across the United States.

Same manufacturer · Abbott Laboratories, Inc

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