Z-0588-2011

Dimension LIP Flex Reagent Cartridge, Catalog# DF55A

Name: Z-0588-2011 Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-03-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-03-10 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension LIP Flex Reagent Cartridge, Catalog# DF55A on 2010-03-10. The reason FDA records is "Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0588-2011
Status: Terminated
Initiated: 2010-03-10
Posted: 2010-12-10
Terminated: 2011-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
Product code: CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Reason for recall: Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post hydration.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recalling firm issued "Urgent Field Safety Notice", dated March 2010, informing users of the problem and to transition to the revised Lipasae method.
Quantity in commerce: 21171
Distribution: Nationwide Distribution throughout the US.
Product codes and lots: Lot Number: DE0320, FC0306, GB0342, EA0334, FB0278, DA0293, GB0286, FA0355, EA0362, EB0362.

Product code CHI

K952816Class ILipase Flex Reagent CartridgeDupont Medical Products / cleared 1995-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)