Z-1311-2018Class II

Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human...

Name: Z-1311-2018 Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human...
Creator: Roche Diagnostics Corporation
Published: 2017-12-22
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2017-12-22 / Terminated / root cause: software

FDA source

Roche Diagnostics Corporation began a recall of Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin) on 2017-12-22. FDA classified it as Class II and gives the reason as "Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1311-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-22
Posted: 2018-04-04
Terminated: 2019-04-05
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Product code: PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Reason for recall: Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 22, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Immediately discontinue use of Elecsys BRAHMS PCT (catalog number 07301715190) reagent lot number 204084 on the cobas e 801 module. " Discard affected product according to local guidelines. " Complete the attached fax form and fax it to 1-800-722-7222. " File this Urgent Medical Device Removal (UMDR) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDR.
Quantity in commerce: 47
Distribution: US Distribution in states of: CA, FL and IN.
Product codes and lots: Elecsys BRAHMS PCT: 07301715190 Lot number 204084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1311-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1311-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-04

Product code PMT

K160729Class IIElecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics / cleared 2016-06-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)