# K953239: Boehringer Mannheim/Hitachi 917 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Sep 25, 1995 after 76 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060373: Cobas 6000 Series System (2006), 18 descendants of its own
- K100853: Cobas 8000 Modular Series Analyzer (2010), 9 descendants of its own
- K041627: Cystatin C Immunoparticles, Control Set, Calibrator (2004), 8 descendants of its own
- K990092: Avl Omni Modular Analyzer (1999), 7 descendants of its own
- K080811: Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set (2008), 5 descendants of its own

## Recalls of this device
- Dec 18, 2017 · Class II · Z-1269-2018: Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.
- Jun 29, 2017 · Class II · Z-0378-2018: 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.
- Jul 15, 2016 · Class II · Z-0094-2017: 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 clarif
- May 7, 2015 · Class II · Z-1922-2015: 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 p
- Nov 12, 2008 · Not classified · Z-1067-2009: 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 res
- Nov 12, 2008 · Not classified · Z-1068-2009: 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 res
- Nov 12, 2008 · Not classified · Z-1065-2009: 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 res
- Nov 12, 2008 · Not classified · Z-1066-2009: 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 res
- Mar 21, 2008 · Not classified · Z-0870-2008: Possible mismatch between patient and result.
- Mar 21, 2008 · Not classified · Z-0867-2008: Possible mismatch between patient and result.
- Mar 21, 2008 · Not classified · Z-0869-2008: Possible mismatch between patient and result.
- Mar 21, 2008 · Not classified · Z-0866-2008: Possible mismatch between patient and result.
- Jul 21, 2006 · Not classified · Z-1447-06: Expired product (dated 2006.06) was shipped as replacement for recalled product.
- Jul 14, 2006 · Not classified · Z-1352-06: A design change in the electrodes will result in incorrect potassium level results.
- Aug 6, 2004 · Not classified · Z-1430-04: A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Aug 6, 2004 · Not classified · Z-1429-04: A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- Aug 6, 2004 · Not classified · Z-1431-04: A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.
- May 8, 2003 · Not classified · Z-0012-04: Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.

Source page: https://510kreport.com/device/K953239
Methodology: https://510kreport.com/methodology