IMMULITE 2000 hCG diagnostic systems recalled for falsely elevated results

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the IMMULITE 2000 Systems hCG diagnostic devices. These systems are used in clinical laboratories to measure human chorionic gonadotropin (hCG) levels. Affected products include the 200-test and 600-test kit variants with specific lot numbers and material numbers.

The recall is due to potential sample carryover in serum samples, urine patient samples, quality control samples, and adjustor solutions. This carryover could cause the device to report falsely elevated hCG results, which may lead to misinterpretation of patient hCG levels and affect clinical decision-making.

Approximately 10,755 boxes have been distributed worldwide, including 533 boxes in the United States across 23 states and 10,222 boxes to 81 countries. The affected production lots are 463, 464, 466, 467, 469, 470, 471, and 472, with distribution dates ranging from February 2022 through February 2023.

Laboratories and healthcare providers using affected IMMULITE 2000 hCG systems should verify the lot number against the recall notice. The FDA recommends reviewing this recall for guidance on appropriate actions. No illnesses or injuries have been reported in connection with this issue.

The recalled product

Product

IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Category

Medical Device — Diagnostic Equipment

Hazard

• sample-carryover
• false-results

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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