Z-0547-2020Class II

V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180

Name: Z-0547-2020 V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Creator: Vital Scientific N.V.
Published: 2018-11-15
License: https://open.fda.gov/license/

VitalScientific / initiated 2018-11-15 / Open, Classified / root cause: manufacturing process

FDA source

Vital Scientific N.V. began a recall of V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 on 2018-11-15. FDA classified it as Class II and gives the reason as "During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0547-2020
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-15
Posted: 2019-11-22
Recalling firm: VitalScientific
Product: V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
Reason for recall: During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On November 15, 2018 the firm sent an Urgent Field safety Notice via E-Mail to all affected consignees. The firm also sent out an updated notifications on November 30, 2018 and January 8, 2019 The customer notification addressed the problem and the conditions in which the problem could happen. the urgent field safety notice asked customers to do follow: 1.ELITechGroup is working with the highest priority on a permanent solution to this problem. Pending this permanent fix, we are requesting your cooperation to carry out this mandatory instruction for each active analyzer used. 2.To guarantee a safe operation of the referenced products the following flowchart and instruction must be followed: A. In case PSID is switched off by default; no further action required B. In case non-barcoded sample container are used, disable the PSID in all instances C. In case barcoded sample containers are used and they are positioned by using the PSID functionality or manually assigned a position, please pay attention to a "b" flag or "barcode not scanned" flag. The b-flag may appear with the result if during the run the barcode could not be verified. Whenever a b-flag is present reject the result and repeat the test for the requested sample. 3. Disabling the PSID: A. Please follow the instructions below to disable the internal barcode reader. Disable PSID when non-barcoded sample containers are used. 4. Disabling the System Barcode A. From the Main Menu, Click F5 Special Functions B. Click F2 Installation C. Select System Parameters D. Set Use System barcode to NO 5.. "b-flag" (barcode not scanned): A. Just before sampling the instrument will scan the barcode. When it cannot read the barcode a b-flag will appear with the result. Whenever the b-flag appears, reject the result and repeat the test. 6. Please check the custom automatic evaluation setting for the b-flag in the [Install menu]. For your convenience you can use the custom automatic evaluati
Quantity in commerce: 732 instruments
Distribution: NY
Product codes and lots: (OUS) V-Twin¿ 6002-800 serial numbers from 3-3021 till 18-3345; (US) V-Twin¿6002-850 serial numbers from 3-3006 till 9-4037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0547-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0547-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code JJF

K973628Class IVitalab Flexor/vitalab Selectra 2/Vitalab VivaVital Scientific N.V. / cleared 1998-03-13

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)