Boehringer Mannheim/Hitachi 917 Analyzer

• • Terminated Z-1269-2018 FDA Class II ·initiated 18 Dec 2017

  Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

• • Terminated Z-0378-2018 FDA Class II ·initiated 29 Jun 2017

  Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.

• • Terminated Z-0094-2017 FDA Class II ·initiated 15 Jul 2016

  Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

• • Terminated Z-1922-2015 FDA Class II ·initiated 7 May 2015

  Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

• 4 recalls, same reason

  • Terminated Z-1066-2009 FDA Unclassified (pre-2012) ·initiated 12 Nov 2008
  • Terminated Z-1065-2009 FDA Unclassified (pre-2012) ·initiated 12 Nov 2008
  • Terminated Z-1068-2009 FDA Unclassified (pre-2012) ·initiated 12 Nov 2008
  • Terminated Z-1067-2009 FDA Unclassified (pre-2012) ·initiated 12 Nov 2008

  If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.

• 4 recalls, same reason

  • Terminated Z-0870-2008 FDA Unclassified (pre-2012) ·initiated 21 Mar 2008
  • Terminated Z-0866-2008 FDA Unclassified (pre-2012) ·initiated 21 Mar 2008
  • Terminated Z-0869-2008 FDA Unclassified (pre-2012) ·initiated 21 Mar 2008
  • Terminated Z-0867-2008 FDA Unclassified (pre-2012) ·initiated 21 Mar 2008

  Possible mismatch between patient and result.

• • Terminated Z-1447-06 FDA Unclassified (pre-2012) ·initiated 21 Jul 2006 ·via K953239, on the same 510(k)

  Expired product (dated 2006.06) was shipped as replacement for recalled product.

• • Terminated Z-1352-06 FDA Unclassified (pre-2012) ·initiated 14 Jul 2006 ·via K953239, on the same 510(k)

  A design change in the electrodes will result in incorrect potassium level results.

• 3 recalls, same reason

  • Terminated Z-1431-04 FDA Unclassified (pre-2012) ·initiated 6 Aug 2004
  • Terminated Z-1429-04 FDA Unclassified (pre-2012) ·initiated 6 Aug 2004
  • Terminated Z-1430-04 FDA Unclassified (pre-2012) ·initiated 6 Aug 2004

  A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

• • Terminated Z-0012-04 FDA Unclassified (pre-2012) ·initiated 8 May 2003 ·via K953239, on the same 510(k)

  Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K953239 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Precimat Glycerol

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• Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844

  Class II

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• Stattek Bun

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  FDA 510(k) K792328 Active Cleared 18 Dec 1979

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  FDA 510(k) K931258 Active Cleared 10 Feb 1994

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