Z-2666-2016Class II

Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be...

Name: Z-2666-2016 Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be...
Creator: Tecan US, Inc.
Published: 2016-07-25
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2016-07-25 / Terminated / root cause: manufacturing process

FDA source

Tecan US, Inc. began a recall of Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of... on 2016-07-25. FDA classified it as Class II and gives the reason as "The batteries have the potential to overheating, melt or char". 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-2666-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-25
Posted: 2016-08-25
Terminated: 2017-01-23
Recalling firm: Tecan U.S.
Product: Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma).
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Reason for recall: The batteries have the potential to overheating, melt or char.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Tecan contacted all customers by Safety Announcement, via certified mail starting July 25, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Because affected batteries pose a fire and burn hazard, it is extremely important that customers check whether their battery is affected. Customers were advised to go immediately to the HP Battery Recall website at: http://www.HP.com/go/batteryprogram2016 to check if their battery is affected by this recall. Customers were also advised to complete and return the Customer Response Form at [email protected] or fax it to 919-287-2961. Customers with questions should contact HP at 1-888-202-4320 or Tecan Technical Service's Helpdesk at 800-832-2687, option 1.
Quantity in commerce: 1 unit
Distribution: Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
Product codes and lots: Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2666-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2660-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2661-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2662-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2663-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2664-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2665-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25
Z-2666-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)