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Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

FDA Recall #Z-1796-2018 — Class II — December 14, 2017

Recall #Z-1796-2018 Date: December 14, 2017 Classification: Class II Status: Terminated

Product Description

Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)

Reason for Recall

Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.

Recalling Firm

Siemens Healthcare Diagnostics, Inc. — Newark, DE

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

Domestic and Foreign consignees

Code Information

Catalog DF56 Lot FB8109- UDI# (01)00842768025532(10)FB8109(17)20180419

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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