Z-1887-2020Class II

Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions...

Name: Z-1887-2020 Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions...
Creator: Inpeco S.A.
Published: 2020-04-07
License: https://open.fda.gov/license/

Inpeco S.p.A. / initiated 2020-04-07 / Open, Classified / root cause: software

FDA source

Inpeco S.A. began a recall of Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or... on 2020-04-07. FDA classified it as Class II and gives the reason as "The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1887-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-04-07
Posted: 2020-05-05
Recalling firm: Inpeco S.p.A.
Product: Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: The firm sent an Urgent Medical Device Correction letter to all affected customers on March 30, 2020. The letter instructed the customers to complete and return the Customer Letter Receipt Confirmation and Implementation Check form. The firm explained that their regular service provider will contact them to schedule the firmware version upgrade.
Quantity in commerce: 65 units
Distribution: Worldwide distribution including the following states: Ohio, New York, Virginia, Pennsylvania, Texas, Delaware, California, Florida, Kentucky, Tennessee, Maryland, Rhode Island, Alabama, Massachusetts, Connecticut, Minnesota, Alabama, Montana, Louisiana, New Jersey, Virginia, New Hampshire, Michigan, North Carolina, Washington, Iowa, New Mexico, Nebraska, and Missouri
Product codes and lots: Serial Numbers: FLX.002, FLX.006, FLX.008, FLX.011, FLX.0121, FLX.0127, FLX.0128, FLX.0129, FLX.0132, FLX.0133, FLX.0139, FLX.014, FLX.0147, FLX.0149, FLX.0150, FLX.0153, FLX.0154, FLX.0160, FLX.0162, FLX.0167, FLX.0168, FLX.0172, FLX.0173, FLX.0174, FLX.0179, FLX.0180, FLX.0182, FLX.0191, FLX.0192, FLX.0193, FLX.0194, FLX.0197, FLX.0198, FLX.0201, FLX.0202, FLX.0203, FLX.0206, FLX.022, FLX.032, FLX.035, FLX.036, FLX.037, FLX.039, FLX.043, FLX.046, FLX.050, FLX.056, FLX.057, FLX.060, FLX.061, FLX.062, FLX.073, FLX.082, FLX.083, FLX.085, FLX.086, FLX.087, FLX.093, FLX.096, FLX.097, FLX.098, FLX.100, SHD.001, SHD.002, SHD.003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1887-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1887-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1888-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1889-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code JJE

K121012Class IIFlexlab 3.6, Accelerator A3600Inpeco S.P.A. / cleared 2012-08-31

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)