Z-1373-2021Class II

MicroScan WalkAway-96 plus Reconditioned Instrument

Name: Z-1373-2021 MicroScan WalkAway-96 plus Reconditioned Instrument
Creator: Beckman Coulter Inc.
Published: 2019-09-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-09-04 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of MicroScan WalkAway-96 plus Reconditioned Instrument on 2019-09-04. FDA classified it as Class II and gives the reason as "Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure". 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-1373-2021
Classification: Class II
Status: Terminated
Initiated: 2019-09-04
Posted: 2021-04-07
Terminated: 2023-01-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan WalkAway-96 plus Reconditioned Instrument
Product code: LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Reason for recall: Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 09/04/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to its customers via electronic and/or first class postal mail informing them that an investigation revealed that some instruments were manufactured with shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. Customers were also informed that when a reagent is not dispensed, there is the potential for any of the following to occur: -high probability misidentifications and reporting of erroneous results -panel reads are flagged with exception requiring investigation (e.g. repeat the panel) causing delayed results. -QC failure requiring investigation (e.g. repeat the panel) causing delayed results The reagent draw straw is shorter than the probe level sensor, thus customers will not be notified by LEDs that the reagent system needs attention. Customers are instructed to: 1) Perform daily maintenance and manually verify the reagent volume in the 30mL bottles. Make sure each 30mL reagent bottle has at least 1 1/4 inch (approximately 1/2 full) of reagent or replace or refill bottles if necessary. 2) If the customer experienced an increase of reagents not dispensing, misidentifications and/or QC failures with their instrument, then a retrospective review of patient results is at the discretion of the Laboratory Director. The Recalling Firm will contact customers to schedule an onsite visit. During the visit the Recalling Firm's representative will install the reagent bottle assembly with the correct reagent draw straw length. Customers are asked to share this information with their laboratory staff and retain the recall notification as part of their laboratory Quality System documentation. If the affected systems have been forwarded to another laboratory, please provide a copy of the recall notification to them. Customers are asked to respond within 10 days that they have received
Quantity in commerce: 9 systems
Distribution: U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.
Product codes and lots: Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1373-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1370-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-07
Z-1371-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-07
Z-1372-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-07
Z-1373-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-14	2021-04-07

Product code LRG

K911400Class IIWalkaway Tm 40Baxter Healthcare Corp / cleared 1991-11-19

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)