Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use...

FDA Device Recall #Z-2153-2014 — Class II — July 1, 2014

Recall Summary

Recall Number Z-2153-2014
Classification Class II — Moderate risk
Date Initiated July 1, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm PerkinElmer Health Sciences, Inc.
Location Waltham, MA
Product Type Devices
Quantity 144 units

Product Description

Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.

Reason for Recall

Risk of incorrect results from samples prepared with Panthera-Puncher 9

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.

Lot / Code Information

Serial Numbers: 20810001 through 20810148

Other Recalls from PerkinElmer Health Sciences, Inc.

Recall # Classification Product Date
Z-2264-2020 Class III PerkinElmer 226 Sample Collection Device Dec 19, 2017
Z-2756-2017 Class III PerkinElmer 226 Sample Collection Device The... May 31, 2017
Z-1101-2017 Class III Program Update Package AutoDELFIA¿ 3.0, Fluorom... Dec 21, 2016
Z-1102-2017 Class III DELFIA¿ PC with V3.0 Software, Fluorometer, for... Dec 21, 2016
Z-1100-2017 Class III AutoDELFIA¿ Plate Processor , Fluorometer, for... Dec 21, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.