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Sertera Biopsy Device recallZ-1170-2025 · Hologic, Inc · initiated Jan 15, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

FDA root cause category: Process control

What the company is doing

On January 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Our goal is to create as little disruption to your practice as possible. Below outlines the next steps for customers with affected product(s): " Please quarantine any product(s) from the impacted lots you currently have in your inventory. Impacted lots can be returned through IQVIA as part of the voluntary recall. Please note that you will be issued a credit on your account for the affected product(s). " Refer to the Customer Response Form Instructions to identify your product inventory that is subject to this action. " Confirm receipt of this communication by completing the online Customer Response Form. Please complete and submit the online Customer Response Form even if you no longer have the affected product in inventory. Hologic has partnered with IQVIA to conduct follow up communications should no response be received to this letter. " Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and the return of all affected products to Hologic. " If you wish to reorder product, please place a new order via your preferred procurement method. We value your business and thank you for your cooperation. If you have any questions about this communication, please contact [email protected] or 1-877-371-4372.

Recall details

Recall number
Z-1170-2025
Status
Open, Classified
Initiated by the company
Jan 15, 2025
Posted by the FDA
Feb 13, 2025
Recalling firm
Hologic, Inc
Quantity
55,335 units
Product code
KNW
FDA submissions
K150169
Distribution
Domestic: Nationwide Distribution

Product description

Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A

Code information (models, lots, serial numbers)

Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K150169 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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